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KMID : 1142220160110010009
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Regulatory Research on Food, Drug & Cosmetic
2016 Volume.11 No. 1 p.9 ~ p.31
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Upgrade of Regulatory Measure for Comparability Evaluation of Biologics Subjected to Changes in Manufacturing Processes
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Nam Doo-Hyun
Kim Hong-Jin
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Abstract
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The quality, safety and efficacy of biologics including vaccines, blood products and antitoxins are considerably dependent on the manufacturing processes. The manufacturing processes may be changed after marketing authorization for a variety of reasons, for the maintenance of production process including replenishment of cell bank, seed lots and reference standards, for the improvement of manufacturing efficiency including changes in manufacturing process, equipment and production scale, for the improvement of quality attribute and stability including changes in starting material, adjuvant, diluent, additive, analytical procedure and acceptance criteria, and so on. However, such manufacturing process change should not have an adverse impact on the quality, safety and efficacy of biologics. Thus, the regulatory measure of biologics after manufacturing process change is needed for the evaluation of its comparability in quality, safety and efficacy. MFDS already established the「Guideline for Comparability Evaluation of Biopharmaceuticals Following to the Manufacturing Process Change」in 2009. However, this guideline is so inclusive for regulatory implementation, even though it exemplified and classified the cases of manufacturing process change in major, moderate and minor change. Recently, EU, Canada and WHO provided a comprehensive guidelines regarding the categorization of manufacturing process change after marketing authorization, reporting process and supplement data depending on fulfillment conditions. Based on their guidelines and scientific knowledge, the preparation of MFDS detailed guideline was proposed by introducing the resonable classification of manufacturing process change of biologics. The reporting procedure after such a change and supporting supplement data based on fulfillment conditions were also suggested.
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KEYWORD
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biologics, manufacturing process change, comparability, evaluation
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